Method of making sterile bedside drainage bag



' Feb. 26, 1963 E. D. G. GARTH 3,079,292

METHOD OF MAKING STERILE BEDSIDE DRAINAGE BAG Filed Jan. 13, 1960 FREE 3 A TTORNEYS.

3,079,292 METHOD OF MAKING STERILE BEDSlDE DRAINAGE BAG Ernest D. G. Garth, Summit, N.J.; L. Chester May and Andrew 13. Young executors of said Ernest l). G. Garth,

deceased Filed Jan. 13, 1960, Ser. No. 2,245 2 Claims. (Cl. 156-269) This invention relates to a method of making a sterile bag.

My invention relates particularly to a disposable sterile bag useful in hospitals and the like for receiving liquids drained from patients. More particularly the invention is directed to a method of making an inexpensive, individual, sealed, sterile bag for urine collection or like purposes. Desirably the bag is transparent and supportable by a hanger on the side of a bed in an unvarying position permitting an accurate reading of the fluid collected therein, and has a cutting line indicated thereon at an upper corner so positioned that when the upper corner of the bag is removed by cutting along said line, the cut edges will form a close fit around a vertical drainage tube that has been inserted through the opening thus formed at said corner.

As it is well known, it is frequently necessary in the care and treatment of patients in hospitals or on sickbeds elsewhere, to employ a catheter for tapping the urinary bladder to drain off the fluid therein. In such instances, it is of course important that the catheter be free from contamination by microbes and bacteria. It is also important to have the bag or other container, into which the fluid is to be drained, free from contamination, as otherwise there is danger of ascending infection from the bag to the patient by way of the catheter or other drainage tube.

Accordingly it is a principal object of my invention to provide an inexpensive, disposable, sterile bag for bedside drainage use. Another object is to provide a method for making such a bag.

My invention will be clear from a consideration of the following description taken together with the drawing in which:

FIG. 1 is a perspective illustration showing in simplified form means suitable for carrying out the method of making the sterile bag according to my present invention;

FIG. 2 is a top view of a preferred form of sterile bag embodying my invention;

FIGS. 3 and 4 are cross section views along the lines III-J11 and IVIV, respectively, of FIG. 2; and

FIG. illustrates the manner in which the catheter or other tube is inserted into the bag after the upper right corner of the bag has been severed along one of the dotted cutting lines shown in FIG. 2.

In describing the preferred embodiment of my invention illustrated in the drawing, specific terminology has been resorted to for the sake of clarity. However, it is not the intention to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

Referring now to FIG. 1, there is shown a plastic tubing 1% being extruded in continuous form from a known type of extrusion machine 12 at a temperature sufficiently high (of the order 450 F.) to kill any living microorganisms, such as bacteria, spores, bacilli, and the like. Shortly after being extruded, the plastic tubing is flattened, as by spaced-apart rollers 14 nad 15, into a socalled lay-fiat form having seamless parallel edges 16 and 18 running longitudinally of the tubing. Soon after 3,0792% Patented Feb. 26, 1953 the tubing 10 is rolled into a lay-flat form, it passes under a printing roller 29 which prints the same information repeatedly on to the tubing at spaced intervals, such information being that desired for the face of the sterile bag. Included, for example, among such desired information may be a series of marker lines 22 suitably marked to indicate the contents in cubic inches at that level. Also included in the information printed may be a solid marker square 24 which may be employed to actuate a bar sealer, as later described; also guide cutting lines, later referred to.

In accordance with my invention, following the printing operation, a continuous hem 30 is placed by pressure in the presence of heat, as by the pressure roler 32, along a line running parallel with the axis of tubing 1t and located a relatively short distance from the seamless edge 18. The hem 3d divides tubing it) longitudinally into a long narrow minor tube 34 lying between hem 30 and seamless edge 18 and into a larger tube 36 (Within main tubing 10) lying between hem 3t) and seamless edge 16.

In further accordance with my invention, narrow line transverse seals are placed by pressure in the presence of heat at spaced intervals transversally to the axis of the tubing 10. Such transverse seals extend from the seamless edge 16 of the tubing 10 up to but not appreciably beyond the hem 30. These transverse seals may preferably, but not necessarily, be in pairs the individual lines of which are closely spaced, such as may be accomplished by the inverted U-shaped sealing bar 4% which is driven down by means 41 at instants controlled by the sensing device 42 in response to the passage of the marker block 24 past a selected point though which a beam of light 31 would have passed from a source not shown had it not been interrupted by the marker block.

A guillotine type of bar knife 43 pivoted at 44 and driven by eccentric mechanism 45 in timed relation to the forward movement of the lay-flat tubing, severs tubing 10 completely through from one seamless edge 18 to the other seamless edge 16 along a transverse line located mid-way between the two transverse line seals of the pair of closely-spaced line seals laid down by sealing bar 40. If desired, instead of a pair of closely-spaced narrowline transverse seals, a single wider line seal may be impressed by the sealing bar and the tubing 10 severed along the middle of such wide seal.

It will now be apparent that when the plastic tubing 10 is repeatedly severed transversely to its axis at spaced intervals, plastic bags 60 are formed which may be con veniently stacked on a platform 61 as shown.

In FIG. 2 is shown the details of the bag 60 formed by the method just described. It will be seen that bag 60 comprises a closed compartment 36a whose width is defined by the sealed edges 46 and 48 and whose height is defined by the seamless edge 16 and the hem 30. Running across the top of the bag, above the closed compartment 36a is a slot 34a open at both ends for receiving a hanger bar by which the bag may be supported. Slot 34a is, of course, a portion of the minor tube 34 previously mentioned. The combination of the bedside bag hanger and the plastic bag of the present application is described in detail and claimed as a new combination in my co-pending application Serial No. 700,432, filed December 3, 1957, which issued November 8, 1960 as US. Patent 2,959,386.

Thus, by the method and means described broadly above with respect to FIG. 1, a continuous tubing of extruded plastic is converted immediately after extrusion into a plurality of bags interiorly sterile and hence peculiarly adapted for use as a disposable bedside drainage container. The plastic employed for the sterile bag of the present invention may be any suitable plastic, one of which is polyethylene. It is, of course, necessary that the plastic employed be impervious to air so that the interior of the bag remains sterile awaiting use. It is also necessary that the plastic be impervious to the fluids or liquids to be contained therein.

Due to the method by which the plastic bag of the present invention is made, the air-tight and liquid-tight compartment 36a of the bag is ordinarily free of bacteria, microbes, bacilli, spores and other living micro-organisms at the time of manufacture, and being air tight, it remains sterile awaiting use.

In practice, after a continuous run of extruded tubing has been formed into bags in the manner just described, the first few bags of the run and the last few bags of the run are tested for sterility, and when found to be sterile, the intervening bags of the run are assumed to be sterile without further test.

In further accordance with a preferred form of my invention, guide lines are printed diagonally across at least one upper corner, preferably the upper right corner of the bag, as indicated in the drawing by the dotted lines 50, 52, to show where, when the bag is about to be used, the bag should be cut to provide an opening to receive the catheter or tube 54. The tube 54 is preferably inserted through the opening substantially at right angles to the cutting lines 59, 52, as shown in FIG. 5 by the solid line representation of the tube 54. Guide lines 50, 52 serve similar purposes, guide line 52 being used where the tube 54 is of larger diameter. After insertion of the catheter or tube 54 into the opening formed by cutting along the lines 5% or 52, the tube 54 is moved to a substantially vertical position as shown by the dot and-dash line representation of the tube in the drawing. It is to be noted that when the tube 54 is inserted substantially at right angles to the cutting lines 50, 52 the opening into the previously closed compartment 36a of the bag is appreciably larger than the right-angle crosssectional area of the tube 54, but that when the tube 54 is moved to occupy the dot-and-dash (vertical) position shown in FIG. 5. the tube 54 fills substantially the entire opening created by the cut along the guide line 50. Moreover, as the catheter or tube 54 is moved from the solid-line to the vertical dot-and-dash line position, the plastic material of. the bag tends to cling around the catheter thus assisting in effecting a substantial closing of the opening around the catheter. Thus, but a very small space is left around the catheter to permit air to escape from the compartment 36a as the bag fills up with fluid. Thecatheter 54 is preferably held in substantially vertical position by a hanger, not shown in the present applicat ion, but shown and described in my aforesaid co-pending application, Serial No. 700,432, US. Patent 2,959,386.

While a preferred embodiment of my invention has been described in some detail, it will be obvious to one skilled in the art that various modifications may be made without departing from the invention as hereinafter claimed.

Having thus described my invention, I claim:

1. The method of forming a sterile plastic bag comprising the steps of extruding a continuous lay-fiat tubing of plastic material, said tubing being transversely continuous and defined by opposing seamless edges running lengthwise of the tubing and being sterile when it issues from the extruder, applying pressure along a line a relatively small distance from one of said seamless edges during movement of said tubing past a point, thereby to form a continuous hem running along one side of said tubing, said hem defining a continuous slot, applying by pressure closely-spaced pairs of transverse seals at relatively widely spaced intervals between said hem and that seamless edge of said tube which is more remote from said hem, and severing said tubing along substantially the center line of each said pair of transverse seals, thereby to form a plastic bag having a slot for receiving a hanger bar and a sealed air-and-liquid-tight compartment which is sterile at the time of manufacture and which remains sterile awaiting use.

2. The method of making a sterile plastic bag suitable for use asa bedside drainage bag, said method comprising the steps of: forming by extrusion a continuous layfiat seamless tubing of plastic material said tubing being transversely continuous and being sterile when it issues from said extruder; forming by heat and pressure a continuous thin-line seal in a longitudinal direction parallel with and relatively close to one seamless edge of said tubing thereby to form a continuous hem running along one side of said tubing; applying heat-pressure seas transversely of the axis of said tubing at spaced-apart intervals, said transverse seals extending between said hem and that seamless edge of said tubing more remote from said hem; and completely severing said tubing transversely at the location of said transverse seals and at substantially the center line thereof, thereby to form a plastic bag having an open-ended slot at the top for receiving a hanger bar and having therebelow a sealed air-andliquid-tight compartment which is steriie at the time of manufacture of said bag and which remains sterile awaiting use.

References (Zited in the file of this patent UNITED STATES PATENTS 2,328,569 McGaw Sept. 7, 1943 2,431,888 Pick Dec. 2, 1947 2,584,632 Southwick Feb, 5, 1952 2,620,944 Stahl Dec. 9, 1952 2,773,285 Piazze et al Dec. 11, 1956 2,878,849 Lingenfelter et al Mar. 24, 1959 2,999,387 Andelin Sept. 12, 1961 3,001,555: Beach Sept. 26, 1961 

1. THE METHOD OF FORMING A STERILE PLASTIC COMPRISING THE STEPS OF EXTRUDING A CONTINUOUS LAY-FLAT TUBING OF PLASTIC MATERIAL, SAID TUBING BEING TRANSVERSELY CONTINUOUS AND DEFINED BY OPPOSING SEAMLESS EDGES RUNNING LENGTHWISE OF THE TUBING AND BEING STERILE WHEN IT ISSUES FROM THE EXTRUDER, APPLYING PRESSURE ALONG A LINE A RELATIVELY SMALL DISTANCE FROM ONE OF SAID SEAMLESS EDGES DURING MOVEMENT OF SAID TUBING PAST A POINT, THEREBY TO FORM A CONTINUOUS HEM RUNNING ALONG ONE SIDE OF SAID TUBING, SAID HEM DEFINING A CONTINUOUS SLOT, APPLYING BY PRESSURE CLOSELY-SPACED PAIRS OF TRANSVERSE SEALS AT RELATIVELY WIDELY SPACED INTERVALS BETWEEN SAID HEM AND THAT SEAMLESS EDGE OF SAID TUBE WHICH IS MORE REMOTE FROM SAID HEM AND SEVERING SAID TUBING ALONG SUBSTANTIALLY THE CENTER LINE OF EACH SAID PAIR OF TRANSVERSE SEALS, THEREBY 